BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL LUMEN INSERTION TRAY

    MDR report key: 4203758 · Received September 18, 2014

    Report

    Report Number
    3009211636-2014-00080
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 11, 2014
    Manufacturer
    COVIDIEN, COVIDIEN MANUFACTURING
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT SAMPLE WAS NOT RETURNED TO THE MANUFACTURING SITE FOR REVIEW AS THE CUSTOMER'S RISK MANAGEMENT HAS ELECTED NOT TO RELEASE THE UVC CATHETER FOR MANUFACTURE INVESTIGATION. A LOT NUMBER WAS NOT PROVIDED, THEREFORE, IT IS NOT POSSIBLE TO PERFORM A DEVICE HISTORY RECORD REVIEW. WITH THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE COULD BE CONSIDERED AS MISUSE (LEAK COULD BE CAUSED MORE LIKELY DUE TO EXCESSIVE FORCE OR A SHARP OBJECT). HOWEVER WITHOUT THE SAMPLE, THIS CANNOT BE CONFIRMED. NO ADDITIONAL ACTIONS ARE REQUIRED. UNDER SPECIAL 510K#K130725, COVIDIEN EXPANDED WARNINGS WITHIN THE INSTRUCTIONS FOR USE MANUAL OF THIS PRODUCT TO HIGHLIGHT THE CONCERN OF UVC CATHETER DAMAGE IN THE HUB AREA ASSOCIATED WITH THE USE OF ALCOHOL BASED DISINFECTANTS. THE INSTRUCTIONS FOR USE WERE REPLACED IN ALL STOCK, AND HOSPITALS WERE SENT A LETTER HIGHLIGHTING THIS ISSUE. IT MUST BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATES: DO NOT USE INSTRUMENTS WITH SHARP OR ROUGH EDGES DIRECTLY ON THE CATHETER SINCE EVEN A MINOR CUT COULD TEAR OR BREAK THE CATHETER AND CONTINUES, DO NOT PINCH OR BEND THE CATHETER BACK TO TEMPORARILY OCCLUDE THE CATHETER. THIS CAUSES INCREASED STRESS ON THE CATHETER WHICH CAN LEAD TO A LEAK OR BREAK. DO NOT USE ALCOHOL, ACETONE, OR ALCOHOL CONTAINING ANTISEPTICS DIRECTLY ON THE CATHETER. CAREFULLY CHECK ANTISEPTIC SOLUTIONS FOR ALCOHOL OR ACETONE. THESE SUBSTANCES MAY CAUSE IRREVERSIBLE DAMAGE TO THE POLYURETHANE WHICH CAN LEAD TO A LEAK OR BREAK. ENSURE GLOVES OR OTHER SURFACES WHICH HAVE ALCOHOL ON THEM ARE COMPLETELY DRY BEFORE TOUCHING OR MANIPULATING THE CATHETER. ALSO UNDER THE SPECIAL 510K#K130725, A DESIGN CHANGE WAS IMPLEMENTED TO INCREASE THE LENGTH OF THE STRAIN RELIEF ON THE LUER HUB OF THE SINGLE LUMEN UVC CATHETERS. THIS CHANGE IS EXPECTED TO REDUCE THE STRESS AND LIKELIHOOD OF KINKING IN THE AREA MOST LIKELY TO BE EXPOSED TO ALCOHOL. THIS CHANGE WAS EXECUTED IN MAY 2014.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). THE CUSTOMER REPORTS A LEAK 1 MIL JUST BELOW THE BUTTERFLY WHERE THE CATHETER IS JOINED. ALCOHOL/BETADINE WAS USED TO CLEAN THE SKIN AREA AND THE AREA WAS COMPLETELY DRIED PRIOR TO INSERTION. IT WAS NOT DIFFICULT TO HANDLE THE CATHETER DURING INSERTION AND WAS NOT DIFFICULT TO SECURE. THE PICC WAS SECURED WITH TEGADERM HUBGUARD. THE PICC WAS INSERTED ON (B)(6) 2014 IN THE LEFT UPPER ARM. THE DUAL LUMEN WAS USED FOR CONTINOUS INFUSION. A 10 MIL WAS USED TO FLUSH THE LINES. CHG/ALCOHOL (HUB ONLY) WAS USED TO CLEAN THE DEVICE. THE PICC WAS REMOVED ON (B)(6) 2014. THE DEVICE WAS REPLACED WITH A COVIDIEN DUAL LUMEN PICC. THE STATUS OF THE PATIENT IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580756 DUAL LUMEN INSERTION TRAY PERIPHERALLY INSERTED CENTRAL CATH LJS COVIDIEN, COVIDIEN MANUFACTURING 43311 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 DA